FDA approves Spectrum's Beleodaq for rare NHL

The US Food and Drug Administration has approved Spectrum Pharmaceuticals’ Beleodaq to treat a rare, aggressive form of non-Hodgkin lymphoma.

The green light for Beleodaq (belinostat) is for the treatment of patients with peripheral T-cell lymphoma, a fast-growing type of NHL. The approval was granted under the FDA’s accelerated approval programmne and is based on results from a study, which enrolled 129 patients with relapsed or refractory PTCL which showed that 25.8% of participants had their cancer disappear or shrink after treatment.

Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, noted that this is the third drug that has been approved since 2009 for PTCL, following accelerated approval for another Spectrum drug Folotyn (pralatrexate) that year and for Celgene’s Istodax (romidepsin) in 2011.

The approval, which came well before Beleodaq’s Prescription Drug User Fee Act date of August 9, has triggered a milestone cash payment of $25 million from Spectrum to partner Topotarget of Denmark. The latter, which is expected to complete its merger this month with France’s BioAlliance Pharma, will also get double-digit royalties as well as sales milestones.